Question 1

What types of medical devices does Altitude Technologies Inc. manufacture?

Accepted Answer

Altitude Technologies Inc. specializes in emergency medical and trauma response devices. Their portfolio includes first aid kits (both non-medicated and medicated), blood transfusion sets, peripheral vascular and intravenous catheterization support tools, pneumothorax catheter insertion sets, airway needles, and cricothyrotomy kits. These products are designed primarily for tactical, field, and pre-hospital medical use, ensuring readiness for critical situations.

Question 2

Where is Altitude Technologies Inc. based, and how does that affect its regulatory standing?

Accepted Answer

Altitude Technologies Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database lists their products, which helps ensure traceability and compliance with U.S. medical device requirements. The classification of their devices (Class I, Class II, or non-classifiable) is determined by the FDA based on risk and intended use.

Question 3

Which regulatory registries or databases list Altitude Technologies Inc.’s devices?

Accepted Answer

Altitude Technologies Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a global standard for identifying medical devices, ensuring transparency in the supply chain and aiding in regulatory oversight. This listing helps healthcare providers, regulators, and other stakeholders verify the identity and compliance status of the company’s products.

Question 4

How are Altitude Technologies Inc.’s devices classified by the FDA?

Accepted Answer

Altitude Technologies Inc.’s devices are classified under the FDA’s regulatory framework as either Class I, Class II, or non-classifiable (N). The classification depends on the risk associated with the device’s use and its intended purpose. For example, single-use first aid kits like their Patrol Officer Kit or MiniFAK are typically lower-risk and may fall under Class I or II, while specialized tools like cricothyrotomy kits or catheterization support kits could carry higher regulatory scrutiny due to their critical medical applications.

Question 5

What distinguishes Altitude Technologies Inc.’s device portfolio from other manufacturers?

Accepted Answer

Altitude Technologies Inc. focuses on trauma response and field medical readiness, particularly for tactical and pre-hospital use. Their devices are designed for portability and single-use scenarios, such as their first aid kits (e.g., Combat Lifesaver Kit or Expedition Kit) and specialized tools like pneumothorax drainage systems or airway needles. This emphasis on emergency preparedness and operational efficiency sets their portfolio apart, catering to military, law enforcement, and wilderness or disaster response applications.

Device	Model / Reference	Registries	Class	Status
Patrol Officer Kit (LEMK-PO), Refill w/SOFTT-W, Contents Only	02171REF	FDA UDI	Class I	Active
Tmm-Fc	05006	FDA UDI	Class II	Active
Expedition Kit, (EPMK) Hard Case, Yellow	01390HC	FDA UDI	N	Active
RMT & UTQ, Multi-Cam	01394MC	FDA UDI	Class I	Active
Combat Lifesaver Kit (TMK-CL), Olive Drab w/CAT	01276OD	FDA UDI	Class I	Active
TMM-DE (Tactical Medical Module-Dental)	01350	FDA UDI	Class I	Active
Chinook LIFE Station, Basic, SWAT Tourniquet	06030	FDA UDI	Class I	Active
Care Under Fire Kit (TMK-CUF), Olive Drab w/SOFTT-W	01272OD	FDA UDI	Class I	Active
MiniFAK (Mini First Aid Kit), Olive Drab	01153OD	FDA UDI	Class I	Active
Combat Lifesaver Kit (TMK-CL), Multi-Cam w/CAT	01276MC	FDA UDI	Class I	Active
Individual Operator Kit, (LEMK-IO), Refill w/CAT, Contents Only	02172REF-CAT	FDA UDI	Class I	Active
IFAK Pouch & Insert Kit, Refill w/SOFTT-W, Contents Only	01239REF	FDA UDI	Class I	Active
Chinook Minimalist Kit	01421RD	FDA UDI	N	Active
K9 TECC Kit, Advanced (TMK-K9A), Black	02322BK	FDA UDI	Class I	Active
IFAK Pouch Kit, Multi-Cam w/SOFTT-W	01235MC	FDA UDI	Class I	Active
TMK-MARCH Kit, Coyote Brown, W/SOFTTW	01437CB	FDA UDI	Class I	Active
Medic Kit (TMK-ME), Black w/SOFTT-W	01278BK	FDA UDI	Class I	Active
Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)	021555	FDA UDI	Class II	Active
Chinook LIFE Pack, Intermediate, SWAT Tourniquet	06021	FDA UDI	Class I	Active
Chinook IDPA Individual Direct Pressure Adjunct	05323	FDA UDI	Class I	Active
SOFTT-W and UTQ, Olive Drab	01392OD	FDA UDI	Class I	Active
Chinook LIFE Kit Basic, SAM XT Tourniquet	10010	FDA UDI	Class I	Active
LEMM-K9HK, Basic Kit	01459	FDA UDI	Class I	Active
TMM-CT-SO (Tactical Medical Module-Chest Tube-Special Operations)	04765	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Coyote Brown w/SOFTT-W	01274CB	FDA UDI	Class I	Active
Cravat/Triangular Bandage, Each	05001	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Black w/CAT	01326BK-CAT	FDA UDI	Class I	Active
Mobile Aid Kit (MAK), Yellow, Hard Case	01376HC	FDA UDI	N	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Olive Drab w/SOFTT-W	01155OD	FDA UDI	Class I	Active
Chinook LIFE Pack, Intermediate, CAT Tourniquet	07021	FDA UDI	Class I	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Refill w/CAT, Contents Only	01155REF-CAT	FDA UDI	Class I	Active
Line Medic Kit, Coyote Brown w/SOFTT-W	01285CB	FDA UDI	N	Active
K9 TECC Kit, Advanced (TMK-K9A), Olive Drab	02322OD	FDA UDI	Class I	Active
Mass Casualty Critical Intervention Kit, (LEMK-MCCI), Black w/CAT	01155BK-CAT	FDA UDI	Class I	Active
SOFTT and UTQ (TMK-UTQ), Coyote Brown	01391CB	FDA UDI	Class I	Active
Line Medic Kit, Multi-Cam w/SOFTT-W	01285MC	FDA UDI	N	Active
Chinook LIFE Pack, Basic, SAM XT Tourniquet	10020	FDA UDI	Class I	Active
Chinook LIFE Kit Advanced, SWAT Tourniquet	06012	FDA UDI	Class I	Active
Medical Operator Kit, (TMK-MO), Coyote Brown w/SOFTT-W	01326CB	FDA UDI	Class I	Active
Chinook LIFE Pack, Intermediate, SAM XT Tourniquet	10021	FDA UDI	Class I	Active
Individual Operator Kit, (TMK-IO), Olive Drab w/SOFTT-W	01274OD	FDA UDI	Class I	Active
LEMK-GSR (Law Enforcement Medical Kit-Gunshot Range), Black	02175BK	FDA UDI	Class I	Active
Line Medic Kit, Multi-Cam w/CAT	01285MC-CAT	FDA UDI	N	Active
C-A-T & UTQ, Multi-Cam	01393MC	FDA UDI	Class I	Active
Chinook LIFE Kit Intermediate, CAT Tourniquet	07011	FDA UDI	Class I	Active
TMK-UTQ Pouch, OD	601324OD	FDA UDI	Class I	Unknown
SOFTT and UTQ (TMK-UTQ), Black w/Black Pull Tab	01391BKLE	FDA UDI	Class I	Active
Intravenous-Intraosseous Kit (TMK-IV/IO), Coyote Brown	01323CB	FDA UDI	Class II	Active
Chinook LIFE Kit Intermediate, RMT Tourniquet <120 lbs	11011	FDA UDI	Class I	Active
Chinook GermPAK	01395	FDA UDI	Class I	Active

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